YOQNEAM, Israel, Oct. 10 /PRNewswire-FirstCall/ -- Given Imaging (NASDAQ:GIVN) announced today that Endoscopy, the official publication of the European Society of Gastrointestinal Endoscopy (ESGE), published the consensus reports from this year's International Conference on Capsule Endoscopy (ICCE), in the October issue. The consensus reports, which define guidelines and algorithms for both PillCam(TM) SB and PillCam(TM) ESO in several disease states, were developed in response to the need to formalize practice guidelines for using capsule endoscopy. More than 400 gastroenterologists from 38 countries attended the meeting and contributed to the resulting documents.
Established in 2002 by Given Imaging, the ICCE is the world's pre-eminent symposium for the exchange of scientific, clinical and practical information about capsule endoscopy. This year's conference was co-chaired by Dr. Blair Lewis from Mt. Sinai School of Medicine in New York, Dr. Jean-Francois Rey, President of the ESGE and Dr. Ernest Seidman, Professor of Medicine and Chair of Inflammatory Bowel Disease at McGill University, Montreal.
"Since the introduction of PillCam capsule endoscopy in 2001, its application has increased far beyond the initial indication of obscure gastrointestinal bleeding," said Blair Lewis, MD, Clinical Professor of Medicine and Gastroenterology at Mount Sinai School of Medicine and Co- Chairman of ICCE. "As a result, it became necessary to establish guidelines and algorithms defining the appropriate role of capsule endoscopy for indications such as suspected Crohn's disease, Celiac disease, and Esophageal Varices." The ICCE Consensus Reports focused on five areas: gastrointestinal bleeding, inflammatory bowel disease, celiac disease, use of bowel preparations and prokinetics, and esophageal capsule endoscopy. Key findings from these reports are outlined below.
Inflammatory Bowel Disease * Capsule endoscopy can identify small-bowel mucosal lesions not seen with
other imaging modalities and may therefore play an important diagnostic
role in the evaluation and monitoring of patients with known or
suspected Crohn's * Capsule endoscopy may have a unique role in assessing mucosal healing
after medical therapy and for assessing early postoperative recurrence
and in guiding therapy * Capsule endoscopy may serve as a sub-clinical marker in asymptomatic
family members and contribute to the understanding of the natural
history of IBD
Obscure Gastrointestinal Bleeding * Capsule endoscopy is the preferred method of mucosal imaging of the
entire small intestine and should be part of the initial investigation
in patients with obscure bleeding * The diagnostic yield of capsule endoscopy is high and can potentially
lead to earlier diagnoses * When integrated into a global patient care plan, capsule endoscopy can
result in more timely treatment, improved patient outcomes, and lower
overall healthcare utilization and costs
Celiac Disease * Capsule endoscopy can be a prognostic test in patients who have
confirmed and treated celiac disease who develop alarming symptoms * Capsule endoscopy could at present be used as an alternative to biopsy
in the initial diagnosis of patients who are unwilling or unable to
undergo endoscopy (EGD) for the histological confirmation of villous
atrophy * Capsule endoscopy may have a future role as an initial diagnostic test
for confirming villous atrophy in patients who are positive for tissue
transglutaminase or emdomysial antibodies
Intestinal Preparations and Prokinetics * Preparations and prokinetics potentially improve the quality of the
examination but the ideal type, dosage and timing have yet to be
determined * A large, multi-center, randomized controlled study was recommended to
evaluate the degree of required intestinal cleanliness, the preferred
preparation, and the role of prokinetics in capsule endoscopy
Esophageal Capsule Endoscopy * Constitutes a new and exciting technique that will have a significant
role in the non-invasive evaluation of patients with esophageal diseases * Esophageal capsule endoscopy may have an important role in the screening
and surveillance of varices in patients with chronic liver disease * For chronic heartburn patients, esophageal capsule endoscopy can be used
as a primary diagnostic tool for GERD-related complications and to
screen for Barrett's esophagus in patients that are unable or unwilling
to undergo EGD. Sensitivity and specificity is comparable to EGD.
* Future trials to validate the efficacy of esophageal capsule endoscopy
for the screening of Barrett's esophagus and esophageal varices are
warranted
For 2006, the ICCE will be held at two locations. The first meeting will take place March 6-7th in Boca Raton, Florida. The second meeting is scheduled for June 9-10 in Paris, France. Information for both meetings is available at http://www.2006icce.com/.
ENDOSCOPY is one of the world's leading journals with respect to scientific impact in the area of gastrointestinal endoscopy. ENDOSCOPY is published by Thieme Publishers, Stuttgart / New York. For more information on ENDOSCOPY's editorial policy as well as on its aims and scope, please visit the journal's homepage at http://www.thieme.de/endoscopy.
About Given Imaging Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam(TM) video capsules for detecting disorders of the gastrointestinal tract. The company's technology platform is the Given(R) Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam(TM) SB capsule is the only naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 50 other countries and has benefited more than 230,000 patients worldwide. The PillCam(TM) ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit http://www.givenimaging.com/.
This press release contains forward-looking statements about Given Imaging, including projections about our business and our future revenues, expenses and profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the impact of the newly adopted SFAS 123R for expensing option-based payments, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities and Exchange Commission. DATASOURCE: Given Imaging CONTACT: Mark Gilreath of Given Imaging Ltd.; or Fern Lazar, , or David Carey, , both of Lazar Partners Ltd., 1-866-GIVEN-IR Web site: http://www.givenimaging.com/ http://www.2006icce.com/ http://www.thieme.de/endoscopy
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